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All Genders
NCT07357571

Preoperative Prediction of Lymph Node Metastasis in T1N0M0 Papillary Thyroid Carcinoma by Using Contrast-enhanced Ultrasound

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-01-22

600

Participants Needed

2

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Similarly, the burden of central lymph node metastasis affects the individualized management of patients with T1N0M0 papillary thyroid carcinoma (PTC): lymph node metastasis is a contraindication to thermal ablation; low-burden lymph node metastasis is suitable for lobectomy; and high-burden lymph node metastasis recommends total thyroidectomy. However, conventional preoperative imaging examinations have low efficacy in diagnosing central lymph node metastasis. This multicenter retrospective cross-sectional study enrolled 600 patients with T1N0M0 PTC who were admitted to our hospital from June 2018 to June 2025 and confirmed by postoperative pathology. Dynamic contrast-enhanced ultrasound (CEUS) images of the thyroid and lymph nodes before surgery were collected for all patients. Two senior ultrasound physicians unaware of the pathological results independently analyzed the images and extracted qualitative and quantitative CEUS features of lesions and suspicious lymph nodes. Taking postoperative pathological results as the gold standard, patients were divided into the high-burden metastasis group, low-burden metastasis group, and non-metastasis group. Univariate and multivariate Logistic regression analyses were used to screen independent predictors, construct a combined predictive model, and draw receiver operating characteristic (ROC) curves and decision curves to evaluate its diagnostic efficacy and clinical practicality. The primary outcome measure was the area under the curve (AUC), and the secondary outcome measures included sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and net benefit. This project is expected to achieve accurate preoperative prediction of the burden of central lymph node metastasis and realize precise and individualized treatment for patients with T1N0M0 PTC.

CONDITIONS

Official Title

Preoperative Prediction of Lymph Node Metastasis in T1N0M0 Papillary Thyroid Carcinoma by Using Contrast-enhanced Ultrasound

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with preoperative assessment of T1N0M0 papillary thyroid carcinoma who had initial surgery between June 2018 and June 2025
  • Diagnosis of papillary thyroid carcinoma confirmed by post-surgery pathology
  • Preoperative conventional ultrasound and contrast-enhanced ultrasound (CEUS) of thyroid and/or suspicious central lymph nodes with complete, quality imaging data
  • Underwent thyroidectomy (lobectomy or total) plus central lymph node dissection for pathological confirmation
  • Complete clinical, pathological, and imaging data available in hospital records
Not Eligible

You will not qualify if you...

  • Received any thyroid-targeted anti-tumor treatment before surgery (e.g., radiotherapy, chemotherapy, targeted therapy, ablation)
  • Having other types of thyroid cancer such as medullary or undifferentiated carcinoma
  • History of neck surgery or radiotherapy affecting cervical lymph nodes
  • Systemic diseases that may affect CEUS imaging (e.g., severe heart failure, liver cirrhosis)
  • Allergy to ultrasound contrast agent components
  • Missing important clinical or imaging data preventing full analysis

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Sun Yat-sen Memorial Hospital

Guangdong, Guangzhou, China, 510000

Actively Recruiting

2

No. 33 Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, Sun Yat-sen Memorial Hospital

Guangzhou, Guangzhou, China, 510288

Actively Recruiting

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Research Team

J

Jingliang Ruan, Doctoral Degree

CONTACT

X

Xinmin Xiao, Master's Degree

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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